Temporary anastomotic seal and method

ABSTRACT

Forming a proximal anastomosis on an aortic wall includes method and instrumentation and apparatus for forming an aortic puncture and inserting into the vessel through the puncture a fluid-impervious sealing element with a protruding retainer. An anastomosis of a graft vessel over the puncture is partially completed with the retainer of the sealing element protruding through the partial anastomosis. The retainer facilitates removal of the sealing element from the partial anastomosis prior to completion of the procedure.

RELATED APPLICATION

This application is continuation of application Ser. No. 10/123,470,filed Apr. 15, 2002, now U.S. Pat. No. 7,947,062, which is acontinuation-in-part of application Ser. No. 10/033,614, filed Dec. 26,2001, now U.S. Pat. No. 6,814,743, of which each of the aforementionedapplications and patent are hereby incorporated herein by referencethereto, in their entireties, and to which applications we claimpriority under 35 USC §120.

FIELD OF THE INVENTION

This invention relates to coronary bypass grafting surgery and moreparticularly to instruments and method to facilitate performing anaortotomy and proximal anastomosis, for example, associated withcoronary artery bypass grafting surgery.

BACKGROUND OF THE INVENTION

Contemporary coronary artery bypass grafting surgery is performed on abeating heart to obviate complications commonly associated with priorsurgical practices of transitioning a patient onto and off of aheart-lung machine that maintained circulation while the heart was inquiescent condition during construction of a coronary arterial bypass.However, performing an aortotomy and a proximal anastomosis on the aortathat is perfused with blood under pressure contribute to substantiallosses of blood in the absence of temporary measures taken to curtailblood flow through the aortic hole. Side-bite and surface-orientedclamping mechanisms have been used to diminish loss of blood during thesurgical procedures of punching the aortic hole and anastomosing thegraft vessel, but such temporary occlusions damage the endothelium anddislodge emboli that may migrate through the circulatory system.Alternative schemes for performing an aortotomy and limiting loss ofblood during the period of anastomosing a bypass graft includeintroducing a plug or seal at the site of the aortotomy, but suchschemes commonly inhibit convenient and rapid completion of the graftanastomosis, and present other complications to be resolved followingthe grafting procedure.

SUMMARY OF THE INVENTION

In accordance with the method and instrumentation of the presentinvention, an aorto-coronary bypass graft is performed using an aorticpunch and instruments that selectively deliver and position seals ofvarious configurations within the punched aortic hole for retentionagainst the aortic wall. The suture anastomosis is performed with thehemostatic seal in place for removal of the seal prior to completion ofthe anastomosis.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a pictorial illustration of the corkscrew aortic punchdisposed for insertion into the aorta through a hemostatic sheath inaccordance with one embodiment of the present invention;

FIG. 2 is a pictorial illustration of the hemostatic sheath penetratedthrough the aortic wall;

FIG. 3 is a pictorial illustration of the hemostatic sheath positionedwithin the aorta as the aortic punch is removed;

FIGS. 4 and 5 are pictorial illustrations of a seal-positioningmechanism for insertion through the hemostatic sheath into the aorta;

FIG. 6 is a pictorial illustration of the hemostatic seal mechanismdeployed from the interior end of the hemostatic sheath;

FIG. 7 is a pictorial illustration of the hemostatic seal mechanismmanually positioned within the punched aortic hole as the hemostaticsheath and hemostatic seal-positioning mechanism are withdrawn;

FIG. 8 is a pictorial illustration of the hemostatic seal retained inplace at the punched aortic hole via an external tensioning mechanism;

FIG. 9 is a pictorial illustration of suture anastomosis performed aboutthe hemostatic seal;

FIG. 10 is a pictorial frontal illustration of the suture anastomosissubstantially completed with the stem of the hemostatic seal positionednear the last stitches;

FIG. 11 is a pictorial frontal illustration of the tubular removalinstrument disposed over the stem of the hemostatic seal in preparationfor removal from the graft site;

FIG. 12 is a pictorial frontal illustration of the hemostatic sealdissembled through the tubular removal instrument;

FIG. 13 is a pictorial frontal illustration of the anastomosis completedupon removal of the tubular removal instrument and tying off of thesuture ends about the segment of the anastomosis from which the tubularremoval instrument is withdrawn.

FIG. 14 is an exploded view of the aortic punch and hemostatic sheath inaccordance with one embodiment of the present invention;

FIG. 15 is a frontal view of the assembled aortic punch and hemostaticsheath prepared for performing an aortotomy according to the presentinvention;

FIG. 16 is an exploded view of the hemostatic seal positioning mechanismthat illustrates the hemostatic seal and tensioning structure indeployed condition and in confined condition;

FIG. 17 is a pictorial illustration of the formation of a hemostaticseal in accordance with one embodiment of the present invention;

FIG. 18 is a pictorial exploded illustration of a hemostatic sealremoval instrument according to one embodiment of the present invention;

FIG. 19 is a flow chart illustrating an embodiment of the surgicalprocess according to the present invention;

FIG. 20 is a pictorial illustration of a sterile kit of the instrumentsfor performing the surgical process according to the present invention;

FIGS. 21a and 21b are pictorial illustrations of other forms oftemporary aortic seal in accordance with other embodiments of thepresent invention;

FIG. 22a is a perspective view of an inflatable, skirted seal accordingto another embodiment of the present invention;

FIGS. 22b-e are pictorial sectional views of another skirted seal andassociated procedures according to the present invention;

FIGS. 23a-c are, respectively, side sectional and top and partialperspective views of another seal in accordance with the presentinvention;

FIGS. 24a-f are perspective views and sectional views of another sealaccording to the present invention;

FIGS. 25a-e are perspective and sectional views of another embodiment ofa seal according to the present invention;

FIGS. 26a-e are respectively sectional views of an expandable sealaccording to another embodiment of the present invention.

FIGS. 27a-d are perspective and sectional and top views of anotherembodiment of a seal according to the present invention;

FIGS. 27e-g are perspective views of other embodiments of sealsaccording to the present invention;

FIGS. 28a-28e are plan views of embodiments of tethered seals inaccordance with other embodiments of the present invention;

FIGS. 28f-28m are pictorial views of tensioning apparatus and deliveryinstruments for tethered seals;

FIG. 29 is a perspective view of another embodiment of a seal accordingto the present invention;

FIGS. 30a-c are sectional views of the seal of FIG. 29 during a surgicalprocedure;

FIGS. 31a-d are sectional views of apparatus for forming and temporarilysealing an aortic aperture in preparation for formation of a proximalanastomosis;

FIGS. 32a-32b are partial perspective views of an aortic punch inaccordance with one embodiment of the present invention; and

FIGS. 33a-33c are partial perspective views of an aortic punch accordingto an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIGS. 1, 2 and 3, there are shown pictorial views ofthe aortic punch 9 configured for penetrating the aorta 17 of a patientin preparation for a proximal anastomosis of a bypass vessel to theaorta of the patient. Specifically, an outer hemostatic sheath 11 iscoaxially disposed over the lower elongated segment 13 of the aorticpunch which supports a corkscrew-type auger 15, as shown in FIGS. 14 and15. The punch and auger 15 are rotated into a wall of the aorta 17 andthe plunger 19 can then be depressed to penetrate the sharpened edge ofthe lower elongated segment 13 through the aorta wall. The punched-outsegment of aorta wall remains captivated on the cork screw 15, and thehemostatic sheath 11 is positioned within the punched hole through theaorta wall. The plunger mechanism 19 and attached elongated lowersegment is removed from the hemostatic sheath 11 that remains inposition through the aorta wall, as shown in FIG. 3. A fluid-tight sealis included within the hemostatic sheath 11 to inhibit outflow of bloodunder pressure from the aorta 17 in which it is positioned.

Referring now to the pictorial illustration of FIG. 4, there is shown aseal-insertion instrument 21 that includes a sheath 23 of outer diametersized to slide within the hemostatic sheath 11, and a plunger 25 that isdisposed to slide axially within the sheath 23 for selectively ejectingthe hemostatic seal structure 27 from its confinement within the sheath23. The hemostatic seal structure 27, as later described herein withreference to FIG. 16, includes resilient members that are confinedwithin the sheath 23 in preparation for positioning and expansion intosealing engagement with the aorta wall, as later descried herein.

Referring now to the pictorial illustrations of FIGS. 5 and 6, theseal-insertion instrument 21 is inserted into the hemostatic sheath 11through the fluid-tight seal therein, and the plunger 25 is depressed toeject a portion of the hemostatic seal structure 27, within the aorta17. The plunger 25 includes an axial lumen therethrough to pass a lengthof line 28 that is attached to the hemostatic seal structure 27. Theproximal end of plunger 25 may also include a hemostatic seal 100through which the length of line 28 passes.

As illustrated in FIGS. 6, 7, 16 and 17, a convex or mushroom-shapedsealing element 29 of the hemostatic seal structure 27 is deployed andmanually restrained within the aorta 17 covering the punched aortic holeas the hemostatic sheath 11 and the seal-insertion instrument 21 areremoved together from the aorta 17. The hemostatic seal structure 27 isthereby liberated from confinement within the seal-insertion instrument21 to expand into sealing engagement with the aorta wall inside thepunched aortic hole.

Referring now to FIG. 16, the hemostatic seal structure 27 includes theconvex or mushroom-shaped sealing element 29, and this sealing element29 includes an integral central stem 30 that is attached via a suturetether 32 to a resilient frame 34 which tensions the suture tether 32.The resilient frame 34 is attached to the length of line 28 that passesthrough an axial lumen through the plunger 25 as the entire structure ispacked in confined configuration within the hollow sheath 23 of theseal-insertion instrument 21. When ejected from the hemostatic sheath 23upon depression of the plunger 25, the resilient frame 34 expands totension the suture tether 32. Manual positioning by the surgeon'sfinger, as shown in FIG. 7, promotes proper sealing of the hole in theaorta as the resilient frame 34 expands to tension the suture tether 32.As thus positioned in this configuration, the resilient frame 34maintains tension on the suture tether 32 that, in turn, supports thesealing element 29 from outside the aorta to provide outwardly-directedresilient biasing force on the sealing element 29. This resilient forceestablishes firm sealing engagement of the sealing element 29 againstthe inside wall of the aorta. In other words, the frame 34 constitutesan expandable frame that, in its expanded state, applies tension betweenthe flange of the sealing element 29 and the inside surface of the aorta17 (i.e., a blood-carrying vessel) via the suture tether 32 as shown inFIG. 8. In addition, the suture tether 32 greatly facilitates removal ofthe resilient frame 34, as later described herein, upon simply cuttingone or both ends of the suture tether 32 away from the resilient frame34 for removal from the sealing element 29. In one embodiment thesuture-tether 32 may pass through the convex segment of the sealingelement 29 to the concave side thereof on both sides of the central stem30. In another embodiment, the suture tether 32 may be tied to thecentral stem 30 closely adjacent the concave surface of the sealingelement 29.

The sealing element 29 is formed in accordance with one embodiment ofthe present invention, as illustrated in FIG. 17. Specifically, a hollowtube 33 of flexible material such as polyvinyl chloride, PEBAX, or otherpolymer material may be extruded about a looped suture 35 or wire orother tensile member for improved tensile strength. Alternatively, asolid, flexible rod of similar material having sufficient tensilestrength may be used. The hollow tube (or solid rod) 33 may be helicallyor spirally wound into the configuration of the mushroom-shaped sealingmember 29, with the central stem. 30 integrally formed thereon. As shownin FIG. 17, the adjacent convolutes of the spirally-wound tube 33 withsuture 35 or other tensile member disposed therein (or solid rod) may beprefabricated so as to be lightly adhered together along a continuousregion of diminished shear strength, through the application of heat andpressure to a thermoplastic material, or through other suitable adhesiveattachments to form a first assembled state of the substantiallyfluid-impervious sealing element 29 having a large profile and that isflexible and resilient for confined packing within the hollow sheath 23of the seal-insertion instrument 21. Light adhesion between adjacentconvolutes of the spirally-wound tube 33 with a suture therein (or solidrod) promotes disassembly of the sealing element 29 to achieve a seconddisassembled state having a reduced profile as shown in FIG. 12 bytearing along a continuous path of diminished shear strength along, theboundary between adjacent convolutes under tension applied to thecentral stem 30, as later described herein. It should be noted that thecentral stem 30 is an integral and continuous portion of the spiralconvolutes (or other meandering pattern) that extend continuously fromthe central stem portion 30 to the outer perimeter of themushroom-shaped portion of the sealing element 29. This assuressubstantially uniform high tensile strength of the hollow tube 33 withsuture 35 disposed therein (or solid rod) over the entire continuouslength of the tube 33 to assure complete removal from the aorta in themanner as later described herein. In one embodiment, the sealing element29 may be formed by winding the hollow tube 33 (or solid rod) around amandrel that includes separable flanges which are axially spaced apartby about the diameter dimension of the tube 33 or solid rod), and thatincludes a central hollow support to house the portion that forms thecentral stem 30. Heat and pressure applied between such flanges causesthermoplastic flow and adhesion between adjacent convolutes in themushroom-shaped portion and to the stem 30 in the central portion of thefluid-impervious sealing element 29 thus formed. Alternatively, bioinertadhesive may be applied to the convolutes and central stem 30 to retainthe shape of the fluid-impervious sealing element 29 thus formed.

Referring now to the pictorial illustration of FIG. 8, the sealingelement 29 is shown disposed in sealing position inside the punchedaortic hole with the integral stem 30 protruding through the hole, andwith suture loop 35 protruding from the proximal end of the stem 30. Itshould be noted that the resilient frame 34 and the suture tether 32 arepositioned on the outer wall of the aorta to exert an outwardly-directedforce on the sealing element 29 to retain it in sealing engagement withthe inner aortic wall, and to prevent inadvertent expulsion of thesealing element 29 from the hole or loss of the sealing element 29 intothe aorta. The sealing element 29 is thus maintained in sealing positionover the hole in the aorta during formation of the proximal anastomosisby suturing the graft vessel 37 onto the aorta 17, as shown in FIGS.9-11. The stem 30 is flexible and can be gently pushed out of the way ofsutures that are stitched about the hole in the aorta and into theproximal end of the graft vessel 37. In this way, the stem 30 is leftprotruding through the anastomosis at a position thereon near the laststitch (or between any adjacent stitches).

Referring now to FIGS. 10-12 and 18, a seal-removal instrument 41includes an outer tube 43 with an inner core 45 that is slidable withinthe outer tube 43 and that carries a hook 47 at its distal end. Theassembly of inner core 45 disposed within the outer tube 43 ispositioned over the stem 30 of the sealing element 29 with the hook 47engaged in the suture loop 35. The outer tube 43 is positioned onto thestem 30 down to the root of its attachment to the mushroom-shapedspiral-wound sealing element 29, and the inner core 45 is then withdrawnfrom the outer tube 43. These motions cause the spirally-woundconvolutes of the sealing element 29 to tear and otherwise disassemblefor convenient removal as a continuous strand 29′, as shown in FIG. 12,of the material from which the spirally-wound sealing element 29 wasformed. Thereafter, the outer tube 43 may be withdrawn and the suturestied off near where outer tube 43 was positioned to complete theproximal anastomosis, as shown in FIG. 13.

Alternatively, the central stem 30 may be formed as an integral part ofthe mushroom-shaped portion of the sealing element 29 with sufficientlength to extend through the outer tube 43 adequately to permit fingergripping of the stem 30 for manual tensioning and removal of thecontinuous strand 29′ through the outer tube 43 without the need for thehooked inner core 45 and associated suture loop 35.

Referring now to the flow chart of FIG. 19, an embodiment of thesurgical procedure performed according to the present invention includesforming an aperture 51 in the aorta wall, as illustrated in FIGS. 1 and2. The hemostatic seal structure in confined configuration within thehemostatic sheath is then introduced 53 into the aorta through the holein the wall thereof. The sealing element resiliently expands 55 insidethe aorta to form a fluid-tight seal over the hole in the wall, and issupported 57 on a tensioned tether from the outside of the aorta. Acentral stem portion of the sealing element is sufficiently flexible tobe pushed away from the locations on the aorta at which suture stitchesare inserted during substantial completion 59 of anastomosing the graftvessel to the aorta over the hole in the wall thereof. The central stemportion of the sealing element thus protrudes through the anastomosisbetween adjacent stitches and is accessible to facilitate removal of thesealing element disposed within the aorta beneath the anastomosis. Thesealing element is removed through a tube that is positioned over thecentral stem portion by applying tensile force to the central stemportion relative to the tube. This disassembles or unravels the sealingelement into a single strand 61 that is removed through the tube 63, asshown in FIG. 12. The ends of the suture adjacent to the location on theanastomosis through which the strand was removed may then be tied off tocomplete the anastomosis 65.

Referring now to FIG. 20, there is shown a pictorial illustration of akit of instruments and components suitable for performing the surgicalprocedure according to the present invention, as previously describedherein. Specifically, at least the seal-insertion instrument 21 and sealremoval tube 43 are packaged within a sealed enclosure 67 that preservesa sterile environment and facilitates convenient shipping and handlingof these components without contamination or damage. Additionally, ahemostatic sheath 11 may be included within the enclosure 67 for usewith a punch (separately available to a surgeon) in the manner aspreviously described herein with reference to FIGS. 1 and 2.

Referring now to FIG. 21a , there is shown a perspective view of a frame71 for a seal in accordance with another embodiment of the presentinvention. In this embodiment, the frame 71 may be formed as a spiral ofresilient material such as nitinol that extends along a continuous pathfrom the central region of the attached stem 73 to an outersubstantially circular periphery 75. This frame 71 may then be coveredwith a thin film or layer of fluid impervious material such as siliconeor latex rubber covering adjacent convolutes to form a mushroom-shapedsealing element that can be disassembled between adjacent convolutes andremoved as a single strand in the manner as previously described herein.Alternatively, the frame portion 75 may be thermally set with adjacentconvolutes in contact with each other to form a seal which can bedisassembled as previously described herein. In one embodiment, theshape-memory characteristics of Nitinol facilitate formation of a frameportion 75 coated with a thin-film of flexible impervious material thatexhibits an initial, contracted state with adjacent convolutes insubstantial contact at ambient or room temperature. Once inserted into avessel in contact with blood at the normal elevated temperature theframe portion expands into the functional mushroom-shaped sealingelement, as previously described herein.

Referring now to FIG. 21b , there is shown a frame 74 including aplurality of flexible, resilient ribs 76 that extend radially from, andare attached to a base of, the central stem 78. The ribs 76 are coveredwith a thin film or layer of a fluid impervious material, for example aspreviously described, to form a mushroom-shaped sealing element that canbe disassembled by reconfiguring the ribs 76 into alignment with thecentral stem 78 from the base thereof. Alternatively, themushroom-shaped sealing element as illustrated in FIG. 21b may be formedas a homogeneous structure of ribs 76 and impervious layer, for example,of silicone rubber of various thicknesses throughout to inhibitinversion of the sealing element under pressure of blood in a vesselsealed by such element. Specifically, the mushroom-shaped sealingelement 74 promotes formation of a fluid-tight seal between theperimeter thereof and the inner, substantially cylindrical wall of thetarget vessel, and also establishes a space about the central stem 78for convenient passage of the suture needle through the vessel wallabout the stem while a fluid seal is maintained at a greater distancefrom the stem. An inversion of the convex or mushroom-shaped sealingelement under the pressure of blood in the vessel is to be avoidedbecause of the diminished resultant space that is thus provided aboutthe stem for suture stitching, and because of the resultant poorer fluidseal that is formed within the vessel.

Referring now to FIG. 22a , there is shown a perspective view of anotherseal according to the present invention including a segmented skirt 77of flexible material such as silicone rubber overlaying an inflatableballoon 79. The skirt and balloon are symmetrically disposed about acentral tube 81 that supplies fluid under pressure to the balloon 79. Inoperation, this embodiment of a temporary seal in the aorta duringformation of a proximal anastomosis facilitates insertion into anaperture in the aorta in an uninflated, constricted condition. In thiscondition, the skirt 77 overlying the balloon 79 and including aplurality of resilient segments disposed approximately in axialalignment with the central tube 81 presents a sufficiently small crosssection to be inserted through an aortic aperture. The balloon 79 isthen inflated to expand the segments of the skirt 77 radially outwardlyfrom the central tube 81 to thereby seal the aortic aperture and providea shield for the balloon 79 during suturing of a graft vessel about theperimeter of the aortic aperture. Prior to completion of theanastomosis, the balloon 79 may be deflated to return the segments ofskirt 77 substantially to axial alignment along the central tube 81 foreasy removal through the anastomosis before completion of the suturing.

In another embodiment of a skirted seal, as illustrated in FIGS. 22b-c ,there is shown a folded, flexible cone 70 with the apex thereof disposedabout the distal end of the flexible tube 68 that communicates withballoon 66. The assembly is collapsed in uninflated and unextendedcondition within the hollow bore of an aortotomy punch, or otherinsertion tube, 72 for positioning within the vessel through the aorticwall. As illustrated in FIGS. 22c and 22d , the balloon 66 is theninflated with fluid under pressure supplied via tube 68 to expand theskirt of the flexible cone 70 to a dimension greater at the outer rimthan the dimension of the aperture in the vessel wall. The insertiontube 68 may be withdrawn from the aperture in the vessel wall to be usedin skew orientation to the initial alignment, as shown in FIG. 22d , toassist in tensioning the flexible tube 68. In this way, the deployed andexpanded cone 70 can be retained in tension against the inner peripheryof the aortic aperture as suture stitching of a graft vessel proceedsabout the aperture. First and last suture stitches, or some segment ofan incomplete anastomosis of a graft vessel to the aorta, remain open orloose to facilitate removal of the cone 70 and balloon 66 and the tube68, as shown in FIG. 22e . Specifically, after the suture stitches arepositioned about the periphery of the aperture and about the tube 68,the balloon is deflated and the skirt of the cone 70 is therebycollapsed for easy withdrawal through the incomplete segment of theanastomosis, and the stitches are thereafter cinched and tied off tocomplete the procedure with negligible loss of blood.

Referring now to FIGS. 23a-c , there are shown embodiments of othertemporary seals according to the present invention. Disc 83 is formed ofseveral raised resilient segments 85 attached to a peripheral ring 87that may be collapsed to a dimension sufficiently smaller than an aorticaperture to facilitate easy installation with the peripheral ring 87disposed within the vessel, and with the raised inner segmentsprotruding through the aperture under the pressure of blood within thevessel. The protruding inner segments thus retain the sealing element 83in place covering the aortic aperture with reduced probability of beingdisplaced from that position by blood flowing under pressure in theaorta. The sealing element 83 may thereafter be distorted or otherwisecollapsed for removal from its sealing position through an incompletesegment of an anastomosis, as previously described herein.

In a similar embodiment, as illustrated in the top and side sectionalviews of FIGS. 23b and 23c , respectively, a flexible peripheral ring 87may be integrally formed with protruding inner segment 85 for attachmentto the external wall of the aorta using adhesive or clips or temporarysutures, or the like, with the protruding inner segments configured tobe disposed within the aperture to form a temporary seal.

In the embodiment of a temporary seal illustrated in FIGS. 24a-f , agenerally L-shaped configuration of pleated and folded flexible membrane89 is disposed to be inserted through an aortic aperture and thereafterunfolded in a circular pattern to form an impervious seal within theaortic aperture in engagement with the internal walls of the aorta.Removal from within the aorta is facilitated by re-folding the membrane89 back to its original L-shaped configuration for removal through apartially-completed anastomosis in the manner as previously describedherein.

Referring now to FIGS. 25a-e , there are shown various configurations oftemporary seals that may be conveniently positioned in and removed froman aortic aperture. Specifically, the resilient plate 91 includes acentral stem 93 and a plurality of sockets or recesses 94 disposed inthe plate 91 about the central stem 93 to receive one or more centeringarm(s) 95 within the sockets 94. In this configuration, the arm, orarms, 95 within the sockets 94 may be manipulated manually to bend ordeform the resilient plate 91 into a diminished configuration, as shownin FIG. 25d , that may be conveniently inserted into the aorticaperture. In addition, the arms 91 inserted in the sockets 94 protrudeupwardly through the aortic aperture and outwardly over the exterior ofthe aortic wall, as shown in FIG. 25c , both to assure centering of theplate 91 within the aperture, and to assure that the plate 91 remains atthe site and is not carried away in aortic blood flow. Alternatively,the plate 91 may include stanchions 96, as shown in FIG. 25e , spacedsymmetrically about the central stem 93 on the top surface, andincluding lateral holes therein through which the arms 95 extend forconvenient insertion and removal of the assembly from within an aorticaperture.

Referring now to FIGS. 26a-e , there are shown sectional views ofanother embodiment of a temporary seal 99 that is manuallyreconfigurable within an aortic aperture to extend lower segments 100radially outwardly from a central stem 103. The extension of segments100 is actuated by axial motion of the central rod 102 relative to stem103 via the linkage between the two elements. The segments carryflexible membranes 105 between segments 100 to form a substantiallycontinuous hemisphere with a flexible-perimeter to follow inter-aorticcontours, as shown in FIG. 26e , to thereby form a liquid-imperviousseal against the inner aortic wall. The outer flange of stem 103 isflexible to form an initial seal against the cut edge of the aortotomybefore segments 100 are deployed. The flexible outer flange of stem 103can be deflected away from the cut edge of the aortotomy to permit asuture needle to pass during formation of an anatomosis. The segmentsthus deployed, as shown in FIG. 26c , also serve as a shield and guideduring suturing of a graft vessel to the aorta. The segments 100 may beretracted toward the central stem 103 to form a unit of smaller crosssection for removal from the site through a partially-completedanastomosis, as shown in FIG. 26 d.

Referring now to FIGS. 27a-d , there is shown another embodiment of atemporary seal according to the present invention in which an insertableboot 111 includes an adhesive outer ring 113 for temporary attachment tothe outer wall of an aorta. Specifically, the boot 111 includes aflexible membrane 115 that is attached to and descends from the outerring 113 for insertion into an aortic aperture. The membrane 115includes a lateral passage 117 that is sealed in fluid-tight engagementwith a lower portion of the membrane 115 formation of and through whichthe aortic punch is located. This relation between the punch and thering assures proper insertion of the seal into the aortic apertureimmediately following the aperture by the punch. A push wire 119 isdisposed about the passage 117 within the confines of the membrane toprovide a convenient retrieval mechanism, as later described herein.

The upper perimeter edge of the membrane 115 includes radially inwarddepressions 121 through which suturing is accomplished, and includesadhesive for temporary attachment to the outer aortic wall.Additionally, the ring 113 is configured as one or more peel-away layersto facilitate positioning the upper perimeter edge of the membrane 115about an aortic aperture.

In operation, this embodiment of a temporary seal shown in FIG. 27a isdisposed on an aortic punch 123, as shown in FIG. 27, with the punch 123positioned through the passage 117 to carry the boot assembly 111 intoan aperture formed in an aortic wall. As the punch is withdrawn, thepush wire 119 is manipulated to insert the lower end of the boot 111into the aperture thus formed, and the outer ring 113 is substantiallycentered about the aperture for adhesive attachment of the upper outeredge to the outer aortic wall, as shown in FIGS. 27c, d . The outer ring113 may be peeled away to leave the slotted upper perimeter edge of themembrane 115 adhered to the outer wall of the aorta. Suturing of a graftvessel over the aortic aperture penetrates the aortic wall through thedepressions 121 without penetrating the membrane 115. Upon partialcompletion of the anastomosis, wire 119 is tensioned to invert themembrane 115 as the passage 117 secured to wire 119 is pulled through anincomplete segment of the anastomosis between stitches, and as the upperadhesive edge of the membrane is released from the outer wall of theaorta. Thereafter, the sutures may be tightened to complete the proximalanatomosis with negligible loss of blood.

Referring now to FIGS. 27e-g there are shown perspective views of othersealing elements in accordance with alternative embodiments of thepresent invention. Each of these sealing elements 112, 114 is formed ofresilient, flexible material such as silicone rubber for temporarilysealing an aortic aperture. An outer perimeter edge 116, 118 of eachsealing element is disposed to form a fluid-tight seal against the innerwall of the aorta as the sealing element 116, 118 is retained in placeunder resilient tension from outside the aorta in a manner, for example,as previously described herein. Such resilient sealing elements maythereafter be collapsed or otherwise reconfigured for removal through anincomplete segment of an anastomosis, as previously described herein.Specifically, the temporary seal 112 includes an outer perimeter edge116 that is configured to conform to the generally cylindrical innerwall of the aorta, with the maximally-elevated portions of the perimeteredge 116 oriented upstream and downstream of an aortic aperture. Theflexible flange inward from the perimeter edge 116 promotes formation ofa fluid-tight seal against surface irregularities of the inner wall andthe descending volume from the inner edge of the flange to the lowerregion of the sealing element provides ample space for manipulating asuture needle during stitching of an anastomosis. Retention of thesealing element 112 covering an aortic aperture is aided by an externaltensioning device that tethers the element in place, as describedherein.

In similar manner, the embodiment of a temporary sealing element 114 asshown in FIG. 27f includes a perimeter edge 118 that is configured toform a fluid-tight seal against the inner wall of the aorta, as shown inthe perspective view of FIG. 27g , with the maximally-elevated portionsof the perimeter edge 118 disposed upstream and downstream of an aorticaperture. The ‘X’-shaped pattern integrally formed in the sealingelement 118, as illustrated in FIG. 27f provides increased rigidityagainst leak-inducing distortion or expulsion of the sealing element 118through an aortic aperture under pressure of blood flowing in the aorta.Retention of the sealing element 118 covering an aortic aperture isaided by an external tensioning device that tethers the element inplace, as described herein.

Referring now to FIGS. 28a-28e , there are shown other tethered sealingassemblies including a disk 125 and one or more tethers 127. In theembodiment illustrated in FIG. 28e , resilient tethers 127 are affixedto an outer ring 129. In this embodiment of a temporary sealing elementaccording to the present invention, the disk 125 seals an aorticaperture from inside the aorta, and is centered and retained in placecovering the aperture by the resilient tethers 127 that are anchored tothe disk 125 near central locations. The tethers 127 are tensioned asattached to the outer ring 129 to assure centering and support fromoutside the aorta for the disk 125 placed inside the aorta. Theresilient, flexible disks 125 in these embodiments may be deformed tosufficiently small dimension to facilitate insertion through an aorticaperture for forming a temporary seal therewith. Specifically, theflexible disks 125 of FIGS. 28a-d may be tethered and externallytensioned for retention in sealing engagement over an aortic aperture inthe manner, for example, as illustrated in FIGS. 28f-28i . In general, atensioning device such as the resilient frame 34 carries a tether 32between resilient arms that exerts a tensile force through the apertureon a sealing element attached to the tether inside the aorta. Attachmentmechanisms and stiffening structures integral with the sealing elementaid in supporting the sealing element in sealing engagement covering anaortic aperture, and in preventing inversion or blow-out of the sealingelement through the aortic aperture.

Also, as illustrated in the pictorial views of FIGS. 28j-28m , suchflexible disk-shaped sealing elements may be introduced into the aortathrough an incision or punched aperture in an aorta in the preparationof an anastomosis of a grafting vessel therewith. Specifically, acombined aortotomy instrument and delivery device as shown in FIG. 28jincludes an outer tube 120 having a plunger 121 axially movable therein,and includes a tissue-cutting linear blade 122 affixed eccentrically tothe distal end of the tube 120 for puncturing an aortic wall. Theplunger 121 is disposed proximal a flexible sealing disk that is rolledor otherwise compacted into the tube 120 near the distal end forward ofthe plunger 121. A suture attached to the sealing disk passes throughthe plunger for subsequent attachment to an external tensioning deviceof a type as previously described herein. Conventional valve-seals aredisposed between the tube 120 and plunger 121, and between the plunger121 and the sutures to permit relative movement therebetween withoutsignificant loss of blood.

In operation, the blade 122 is positioned to puncture the aortic walland the tapered distal end of the tube 120 facilitates incursion throughthe puncture of the distal end into the aorta. Thus positioned, theplunger 121 is depressed relative to the tube 120 to deploy the sealingdisk into the aorta from its compacted position near the distal end ofthe tube 120. The resilient sealing disk extends to dimensionssufficiently large to cover the puncture, with the attached tetherextending through the puncture. A tensioning device such as a resilientframe 34 is then attached to the tether to exert force on the sealingdisk from the external wall of the aorta to retain the sealing disk insealing engagement with the interior aortic wall covering the puncture.An assembly of sealing disk and tether and tensioning frame may beconfined within a delivery tube 123, as shown in FIG. 28m for deploymentof the sealing disk within an aorta in a manner similar to the procedureas previously described herein with reference to FIGS. 4-9.Alternatively, two-part delivery apparatus may include an aortotomypunch and a separate delivery tube, as illustrated in FIG. 28 l.

Each of the sealing disks illustrated in FIGS. 28a-28d may be similarlypositioned as a temporary aortic sealing element, with variations inconfigurations associated with modifications in the surgical proceduresinvolved in their applications. Specifically, the sealing disk of FIG.28a includes a protruding central ridge or backbone to promote stiffnessagainst distortion and to facilitate grasping with forceps forpositioning and removal from within an aorta. The sealing diskillustrated in FIG. 28b includes a central stem as a single tether bywhich tension may be externally applied to retain the disk in sealingengagement with the internal wall of an aorta. The sealing diskillustrated in FIG. 28c also includes a centrally-located flexibletether and a more rigid upstanding frame to enhance positioning of thedisk centrally within an aortic aperture. The sealing disk illustratedin FIG. 28d includes multiple radially-oriented corrugations between theouter upturned peripheral edge and the central elevated region at whicha tether is attached. The central elevated region promotes centralpositioning within an aortic aperture, and the radial corrugations aidin isolating movements of the central region from disturbing theperipheral seal against the inner wall of an aorta. The upturnedperipheral edge greatly facilitates formation of a good fluid-tight sealagainst an irregular surface of the inner wall attributable to stenoticlesions, or plaque, or the like.

Referring now to FIG. 28e , there is shown a flexible sealing disk 125with multiple resilient tethers 127 extending therefrom to a surroundingring of substantially rigid configuration. In this embodiment, the diskmay be positioned within an aortic aperture, with the tethers 127extending up through such aperture to their attachments to thesurrounding ring that remains positioned on the outer wall of an aortaduring formation of an anastomosis therewith. All of the tethers 127,except one, may then be cut and the disk 125 may be removed from theaortic aperture through an incomplete segment of the anastomosis bypulling on the remaining tether. The anastomosis may then be completedin a manner as previously described herein.

Referring now to FIG. 29, there is shown a perspective view of atemporary seal in accordance with another embodiment of the presentinvention. The seal 131 includes an annulus-shaped balloon 133interposed between an upper sealing member 135 and a lower supportmember 138, as shown in FIGS. 30a-c . The balloon 133 is connected via alumen 132 through the central support stem 137 and frame 141 to a supplyof fluid under pressure for selective inflation of the balloon 133 toform a temporary seal. As illustrated in FIG. 30a , the compositesealing element includes the upper sealing member 135 and the lowersupport 138, with annulus-shaped balloon 133 disposed between the upperand lower layers. All such layers and deflated balloon 133 are foldedinwardly about the central stem 137 to a configuration of sufficientlysmall cross section to be insertable into an aortic aperture. Then, asillustrated in FIG. 30b , the balloon 133 may be inflated to exertsealing force of the upper sealing member 135 relative to the lowersupport member 138 and against the frame 141 disposed on the outeraortic wall. The upper sealing member 135 provides a shield for theballoon 133 against inadvertent puncture during suturing of ananastomosis, as shown in FIG. 29. Thereafter, the balloon 133 may bedeflated and the sealing assembly folded inwardly and distally of theinner end of stem 137 for removal from the aorta through a partiallycompleted anastomosis, as shown in FIG. 30c . The stitches between theaorta and graft vessel are then tightened to complete the anastomosiswith negligible loss of blood.

Referring now to FIGS. 31a-d , there are shown pictorial cross-sectionalviews of apparatus according to the present invention for forming anaortic aperture and deploying a temporary seal to cover the aorticaperture. Specifically, an outer cylindrical sheath 151 includes asharpened distal edge 153, and also includes a screw-like auger 155rotatably supported therein in close-fitting engagement with the innerwall of the sheath 151. The sheath 151 also includes an auxiliary sheath157 attached at a skewed angle to the sheath 151 for housing andselectively deploying a temporary seal 159.

In operation, the auger 155 is rotated within the sheath 151 to augerinto the wall of a vessel such as the aorta, as shown in FIGS. 31a-c .The sharpened distal edge 153 of the sheath in combination with thescissors-like shearing action of the outer edge of the auger againstthis sharpened distal edge 153, penetrates the aorta wall and forms aplug 159 of tissue that remains captive on the auger 155 and insubstantially fluid-tight sealing engagement with the inner wall ofsheath 151. The sheath is inserted into the aorta wall to a depthlimited by protruding flange 161 on the outer wall of the sheath 151. Asthe plug 159 of tissue is withdrawn proximally within the sheath 151, anexpandable seal 163 confined within the auxiliary sheath 157, as shownin FIG. 31c , is advanced into position near the distal end of thesheath 151, as shown in FIG. 31d . A flexible stem or push wire 165 isattached to the seal 163 to facilitate manual placement of the seal 163,and the stem 165 passes through a sliding seal 167 near the proximal endof the auxiliary sheath 157. Thus, the plug 159 of tissue cut from theaorta wall seals the sheath 151, and the sliding seal 167 seals theauxiliary sheath 157 as the plug 159 is withdrawn within the sheath 151and the expandable seal 163 is inserted into the aorta through theaperture cut by the edge 153 of the sheath 151. The expandable seal 163of a type, for example, as previously described herein resilientlyexpands to cover the aortic aperture as the sheath 151 is withdrawn fromthe aortic aperture and the sliding seal 167 passes over the length ofthe stem 165. An aortic aperture is thus formed and temporarily sealedwith negligible loss of blood in preparation for formation of a proximalanastomosis, as previously described herein.

Referring now to FIG. 32a , there is a shown a partial sectional view ofa punch suitable for forming an aortic aperture. Specifically, the punch185 includes a blade with a sharpened edge 175 on the forward or distalend thereof for forming an incision as the punch 185 is inserted intothe aorta. A shaft 187 of reduced cross-section relative to the punch185 supports the punch 185 within an aortic incision with the peripheraledge of the central bore of the anvil 171 aligned with the proximal edgeof the punch 185 on a syringe-type device, as shown in FIG. 32b .Manipulating the plunger 187 toward the finger grips 186 retracts theedge of the punch 185 in tissue-shearing passage through the peripheraledge of the central bore to form a well-shaped aortic aperture.

In operation, a surgeon forms a small linear incision in an aortic wallwith the blade 175 as the punch 185 is inserted into the aorta. Thepunch is then retracted into the bore of the anvil to shear the aorticwall substantially in the shape of the punch and anvil 185, 171, withthe plug of tissue to be removed captivated on the syringe-type deviceshown in FIG. 32 b.

Referring now to FIGS. 33a-33c there are shown partial perspective viewsof an auger-like aortic punch in accordance with an embodiment of thepresent invention. The punch includes an outer cylindrical or ellipticalanvil 171 with an internal bore that receives therein the auger 173 intranslational (and optionally rotational) orientation. The lower edge ofthe cylindrical anvil 171 may be sharpened about the forward edge 175 ofthe internal bore to receive the auger 173 in close translational (and,optimally rotational) fit. A centering point 177 is attached to thedistal or forward end of the auger 173 and a support shaft 179 isattached to the proximal end of the auger 173. The convolutes of theauger 173 are spaced apart and complete at least one turn about thecentral axis of the device. At least the trailing or proximal edge ofeach convolute of the auger is sharpened to promote tissue-shearingaction against the sharpened edge 175 of the cylindrical anvil 171. Inthis way, the auger 173 may be inserted into tissue such as the aorticvessel wall with the centering point 177 initially penetrating thetissue. Then, by rotating the auger (and, optionally, the anvil 171),the convolutes of the auger penetrate the tissue through a smallaperture of approximately the sectional dimension of the centering point177 or the sectional dimension of a convolute. Thus, when used to forman aortic aperture against the pressure of blood flowing therein,resilience of the aortic wall and the small sectional dimension of theaperture thus formed therein permit negligible leakage of blood.

Then, by retracting the auger 173 into the internal bore of the anvil171, tissue entrained on the auger 173 is drawn against the distal edgeof the anvil 171, and is sheared between a sharpened proximal edge of aconvolute and the distal edge of the anvil 171. In this way, a circularor elliptical aperture can be cut in the aortic wall for use, forexample, in creating a coronary arterial bypass graft. The supportingshaft 179 and anvil 171 may be mounted on a syringe-style actuator, asshown in FIG. 33c , to establish relative translational motion betweenthe anvil 171 and the auger 173 in response to the palm pad 181 beingmanually actuated toward finger grips 183.

Therefore, the surgical devices and procedures according to the presentinvention for forming a temporary aortic seal during proximalanastomosis of a graft vessel to the aorta greatly facilitate removal ofthe temporary seal with negligible risk of any residual debris beingcreated thereby to circulate in blood flowing in the aorta or in thegraft vessel. Additionally, sealing elements of the present inventionfacilitate temporarily sealing an aortotomy during formation of thevessel graft. A frame may be disposed outside the aorta to support thesealing element during formation of the anastomosis for easy removal ata convenient stage in the procedure. The sealing element thus positionedto seal off the aortotomy during formation of the anastomosis can beconveniently disassembled for removal from the surgical site withminimal additional trauma or complication of the surgical procedure.

What is claimed is:
 1. An apparatus for forming a temporary andsubstantially fluid-tight seal on an inner wall of a fluid conduitwithin a patient's body, the apparatus comprising: a substantiallyfluid-impervious flange comprising an outer periphery and a stem,wherein the flange comprises a tube of polymer material with a tensilemember disposed in the tube, wherein adjacent convolutes of the tube areattached to one another by adhesion to form the flange and wherein theflange is configured to be selectively disassembled between the adjacentconvolutes.
 2. The apparatus of claim 1, wherein substantially all ofthe flange can be disassembled along a continuous region of diminishedshear strength between the adjacent convolutes by destructive shearfailure.
 3. The apparatus of claim 1, wherein the apparatus isconfigured to at least partially disassemble along a continuous regionof diminished shear strength between the adjacent convolutes as a resultof tension applied to a portion of the stem.
 4. The apparatus of claim1, wherein the flange in an assembled state can be confined forinsertion into an aperture in a vessel in a confined form andsubsequently liberated to seal the aperture in an expanded form.
 5. Theapparatus of claim 4, wherein the flange when in a disassembled stateachieves a continuous strand profile that is smaller than aspirally-wound profile of the flange in an assembled state.
 6. Theapparatus of claim 1, wherein the apparatus is biocompatible and forms aseal during an anastomosis procedure, and wherein the flange has aconcave shaped configuration comprising a concave cap defined by theouter periphery, and wherein a region between adjacent convolutes has adiminished shear strength, that is formed in the concave cap and extendsfrom the stem to the outer periphery, and wherein the concave cap isadapted for forming a hemostatic seal on an inner wall of a blood vesselto facilitate performing an anastomosis.
 7. The apparatus of claim 1,wherein the apparatus is a biocompatible, surgical apparatus adapted forforming a hemostatic seal on an inner wall of a blood vessel and whereinthe substantially fluid-impervious flange is resiliently flexible suchthat in a first confined configuration the flange is inserted through anopening in the blood vessel and in a second expanded concaveconfiguration the flange has an outer periphery larger than the opening,forming a concave hemostatic seal with the inner wall of the bloodvessel and providing a space for passage of a suture needle about thestem to perform an anastomosis while maintaining the hemostatic seal ata location further from the stem.
 8. An apparatus for forming atemporary fluid-tight seal on the inner wall of a fluid conduit within apatient's body, the apparatus comprising: a flange comprising a tube ofpolymer material with a suture disposed in the tube and a continuouspath of diminished shear strength formed within the flange, whereinadjacent convolutes of the tube are attached to one another by adhesionand the flange is configured for disassembling between the adjacentconvolutes of the tube, wherein the flange further comprises an outerperiphery and a stem configured to protrude through an aperture in awall of the fluid conduit, wherein tension applied to the flangedisassembles the flange between the adjacent convolutes so the flangemoves between an assembled state and a disassembled.
 9. The sealingelement of claim 8, further comprising a support structure connected tothe flange, wherein the flange is configured for sealing an aperturewithin a blood-carrying vessel, and the support structure comprises aresilient, expandable frame that in an expanded state applies tensionbetween the flange and an inside surface of the blood-carrying vesselfor purposes of forming a fluid tight seal between the flange and aninside surface of the blood-carrying vessel.
 10. A sealing element forforming a fluid-tight seal within a patient's body, comprising: a flangecomprising a spirally-wound tube of polymer material with a tensilemember disposed in the tube, the flange having an assembled state and adisassembled state and is further configured to tear between adjacentconvolutes of the tube that are attached to one another so as totransform the flange from the assembled state to the disassembled state;wherein while in the assembled state the flange is substantiallyimpervious to bodily fluids.
 11. The sealing element of claim 10,wherein the flange comprises a single continuous strand of the tube. 12.The sealing element of claim 11, wherein the strand has two oppositeends; and wherein portions of the strand between the two ends areremovably connected to each other.
 13. The sealing element of claim 12,wherein one end of the strand is removably connected to another portionof the strand and the opposite end remains free.
 14. The sealing elementof claim 13, wherein application of a tension force to the opposite enddisconnects the removably connected portions of the strand so as totransition the flange from the assembled state to the disassembledstate.
 15. A method for forming a temporary fluid-tight seal about anaperture within a wall of a fluid-carrying vessel within a patient'sbody, the method comprising: inserting a resilient flexible sealingelement into the fluid-carrying vessel, wherein the resilient flexiblesealing element is the sealing element according to claim 10; retainingthe flexible sealing element against an inner wall of the fluid-carryingvessel and in a sealing relationship with the aperture of thefluid-carrying vessel; reconfiguring the flexible sealing element fromthe assembled state to the disassembled state; and removing the flexiblesealing element from the fluid-carrying vessel while in the disassembledstate.
 16. The method according to claim 15 further comprising initiallyconfining the flexible sealing element in a confined configuration priorto the step of inserting.
 17. The method of claim 15, wherein theresilient flexible sealing element comprises a continuous region ofdiminished shear strength along which the flexible sealing element istransformed from the assembled state to the disassembled state duringthe step of reconfiguring the flexible sealing element.
 18. A sealingelement for forming a fluid-tight seal within a patient's body,comprising: a flange comprising a tube of polymer material with atensile member disposed in the tube, wherein the flange is configured totransform from an assembled state to a partially disassembled state bytearing occurring between adjacent convolutes of the tube that areattached to one another; and a support structure connected to theflange; wherein the flange while in the assembled state is substantiallyblood impervious.
 19. The sealing element of claim 18, furthercomprising a stem extending from the flange.
 20. The sealing element ofclaim 19, wherein the flange is at least partially concave in shape whenin the assembled state.
 21. The sealing element of claim 19, wherein thesupport structure comprises an expandable frame, and wherein the frame,in an expanded state, applies tension between the flange and an insidesurface of a blood-carrying vessel.
 22. The sealing element of claim 18,wherein the flange comprises a single continuous strand of the tube andthe adjoining convolutes integrally attach portions of the flange to oneanother.
 23. The sealing element of claim 22, wherein the strand has twoopposite ends; and wherein and portions of the strand between the twoends are attached to and removably connected to each other between theadjacent convolutes.
 24. An apparatus for forming a temporaryfluid-tight seal on the inner wall of a fluid conduit within a patient'sbody, the apparatus comprising: a flange capable of being at leastpartially disassembled by shear failure along a continuous path ofdiminished shear strength within the flange, wherein the continuous pathof diminished shear strength attaches portions of the flange to oneanother, wherein the flange further comprises an outer periphery and astem configured to protrude through an aperture in a wall of the fluidconduit, wherein tension applied to the flange provides for at leastpartial disassembly of the flange to move between an assembled state anda partially disassembled state; a support structure; and a tetherconnecting the support structure to the flange, wherein the flange isconfigured for sealing an aperture within a blood-carrying vessel, andthe support structure comprises a resilient, expandable frame that in anexpanded state applies tension between the flange and an inside surfaceof the blood-carrying vessel via the tether extending from the frame tothe flange for purposes of forming a fluid tight seal between the flangeand an inside surface of the blood carrying vessel.
 25. A sealingelement for forming a fluid-tight seal within a patient's body,comprising: a flange configured to transform from an assembled state toa disassembled state, wherein transforming from the assembled state tothe disassembled state is achieved at least partially due to tearingoccurring along a region of diminished shear strength of the flange; asupport structure that comprises an expandable frame; and a tetherconnecting the support structure to the flange; wherein the flange whilein the assembled state is substantially blood impervious, and whereinthe frame, in an expanded state, applies tension between the flange andan inside surface of a blood-carrying vessel via the tether.
 26. Asealing element for forming a fluid-tight seal within a patient's body,comprising: a flange comprising a tube of polymer material with atensile member disposed in the tube forming a plurality ofspirally-wound convolutes, wherein adjacent convolutes are attachedtogether, and the flange has an assembled state and a disassembled stateand is configured to transform from the assembled state to thedisassembled state by detaching adjacent convolutes, wherein the flangehas a different profile in the disassembled state than in the assembledstate; wherein while in the assembled state the flange is both concavein shape and substantially impervious to fluid.
 27. The sealing elementof claim 26, wherein the tensile member has a higher tensile strengththan the tube of polymer material.
 28. The sealing element of claim 26,wherein the adjacent convolutes are attached together by adhesion. 29.The sealing element of claim 28, wherein the adhesion is provided bythermoplastic flow between adjacent convolutes or by an adhesive. 30.The sealing element of claim 26, wherein the adjacent convolutes areattached together by thermoplastic flow between the adjacent convolutes.31. The sealing element of claim 26, wherein the adjacent convolutes areattached together by adhesion and by thermoplastic flow between theadjacent convolutes.